The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled the Model 2868 Application loaded on the 3120 ZOOM LATITUDE programmer, a device used to communicate with certain Boston Scientific implantable pulse generators. The recall affects 17,172 units distributed worldwide due to the potential for unanticipated software anomalies to occur when the programmer communicates with certain Boston Scientific transvenous defibrillators.
The recalled devices are identified by UPN 00802526434723 and specific serial numbers beginning with 051026 through 055856. The source document does not specify a remedy or any actions consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Reason for recall: There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators. Distribution: Worldwide Distribution Quantity: 17,172 units in total Lot/code info: UPN: 00802526434723, Serial Numbers: 051026, 051075, 051091, 051121, 051146, 051156, 051171, 051182, 051207, 051232, 051236, 051239, 051270, 051320, 051335, 051358, 051367, 051370, 051374, 051413, 051418, 051425, 051432, 051435, 051456, 051459, 051473, 051478, 051486, 051487, 051495, 051501, 051511, 051533, 051535, 051549, 051552, 051558, 051561, 051580, 051584, 051592, 051593, 051612, 051623, 051626, 051632, 051640, 051655, 051696, 051727, 051745, 051763, 051769, 051770, 051784, 051808, 051818, 051846, 051850, 051863, 051906, 051924, 051931, 051989, 051997, 052018, 052022, 052030, 052034, 052088, 052131, 052145, 052202, 052320, 052460, 054970, 054981, 054993, 054996, 055007, 055016, 055020, 055023, 055037, 055041, 055048, 055059, 055065, 055066, 055069, 055070, 055079, 055086, 055089, 055098, 055113, 055117, 055122, 055132, 055142, 055148, 055154, 055157, 055172, 055174, 055191, 055193, 055205, 055211, 055213, 055214, 055219, 055227, 055246, 055248, 055253, 055256, 055270, 055277, 055306, 055330, 055336, 055343, 055344, 055345, 055350, 055360, 055362, 055376, 055386, 055387, 055388, 055416, 055424, 055449, 055454, 055479, 055501, 055507, 055527, 055537, 055541, 055546, 055568, 055570, 055578, 055580, 055586, 055591, 055625, 055641, 055650, 055658, 055662, 055665, 055666, 055675, 055676, 055677, 055689, 055693, 055697, 055703, 055709, 055721, 055726, 055733, 055735, 055743, 055747, 055750, 055755, 055758, 055789, 055791, 055793, 055799, 055800, 055812, 055813, 055818, 055856,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.